The first and second editions of IEC 60601-1 were based on a "philosophy" quite different from the general standard of safety systems E/E/PES IEC 61508; the new edition, the third, albeit remaining substantially different from the IEC 61508, adopts a "new philosophy" that has more points of contact with it, in fact introduces a greater interaction between the manufacturing and laboratory tests, especially, the standard introduces the concept of EP (Essential performance) defined as the "performance" necessary to obtain the absence of unacceptable risks or, if you prefer, the degradation or the lack of EP, which is the condition that can lead to an unacceptable risk.
The philosophy of the new edition of IEC 60601-1 is therefore based more on the risk management, taking into account a renewed Risk Management File (RMF). In fact, about that, reference is made explicitly to risk management defined in the ISO 14971, to which you must necessarily refer. Basically you can not get an IEC 60601-1 certification, if the medical electro-medical device is not also compliant with ISO 14971.
The section 14 of IEC 60601-1 , in short, is the customization, for the software, of the section 4 of the standard and contains the requirements for the following areas: risk management plan; PEMS development life-cycle; risk management process; specification of requirements; architecture, design and implementation detail; verification & validation of PEMS; changes; requirements for a PEMS to be added to an IT network.
In a particular way, with regard to the section 14 of the Standard (the section dedicated to PEMS), HINTSW - T & T Systems is able to provide, to the manufacturing industry and to test and analisys laboratories an adequate support for all activities to do in the software development and in the software risk management process. In this context, the main responsibilities are: